NDC 53964-002

TEPADINA

Thiotepa

TEPADINA is a Intracavitary; Intravenous; Intravesical Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Adienne Sa. The primary component is Thiotepa.

• Product ID: 53964-002_4f4fe702-275a-24c3-e054-00144ff88e88
• NDC: 53964-002
• Product Type: Human Prescription Drug
• Proprietary Name: TEPADINA
• Generic Name: Thiotepa
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
• Marketing Start Date: 2017-01-26
• Marketing Category: NDA / NDA
• Application Number: NDA208264
• Labeler Name: ADIENNE SA
• Substance Name: THIOTEPA
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Alkylating Acti
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 53964-002-02

1 VIAL, GLASS in 1 BOX (53964-002-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

• Marketing Start Date: 2017-01-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53964-002-01 [53964000201]

TEPADINA INJECTION, POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA208264
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-01-26
• Marketing End Date: 2017-03-02

NDC 53964-002-02 [53964000202]

TEPADINA INJECTION, POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA208264
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-01-26
• Marketing End Date: 2018-08-01

Drug Details

Active Ingredients

Ingredient	Strength
THIOTEPA	100 mg/1

Pharmacological Class

• Alkylating Activity [MoA]
• Alkylating Drug [EPC]

NDC Crossover Matching brand name "TEPADINA" or generic name "Thiotepa"

NDC	Brand Name	Generic Name
53964-001	TEPADINA	THIOTEPA
53964-002	TEPADINA	THIOTEPA
70121-1630	TEPADINA	THIOTEPA
70121-1631	TEPADINA	THIOTEPA
0143-9309	Thiotepa	Thiotepa
0143-9565	Thiotepa	Thiotepa
25021-246	Thiotepa	Thiotepa
43598-171	Thiotepa	Thiotepa
43598-650	Thiotepa	Thiotepa
54879-014	Thiotepa	Thiotepa
65219-029	Thiotepa	Thiotepa
68083-446	Thiotepa	Thiotepa
68083-503	Thiotepa	Thiotepa
69539-123	Thiotepa	Thiotepa
69539-124	Thiotepa	Thiotepa
70860-220	Thiotepa	thiotepa
72205-045	Thiotepa	Thiotepa
72205-046	Thiotepa	Thiotepa